Advanced CancerNCT00507754
Latent Tuberculosis Infection in Cancer Patients
An observational study of Advanced Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objective: 1. To evaluate the performance of the new T-SPOT.TB test and the conventional TST for screening of Latent Tuberculosis infections in patients with cancer and those undergoing Hematopoietic Stem Cell Transplant. Secondary Objectives: 1. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- T-SPOT TB test
- Type of treatment
- Injection or infusion
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study participants with cancer at risk for developing active tuberculosis (TB).
Who may be able to join
- Males and females.
- Patients who are receiving chemotherapy for hematologic malignancy and solid-organ cancer.
- Patients with a Hematopoietic stem cell transplantation (HSCT) history will be included after >1 year of transplantation.
Who cannot join
- Refusal of consent
- Individuals who, on the advice of the Primary or enrolling physician, may otherwise be at increased risk of an adverse reaction to venipuncture or tuberculin skin test administration.
- Lymphocytopenia (< 300 cells/microliter)
- Patients with known HIV infection.
- Patients with known active tuberculosis will not be included in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Latent Mycobacterium Tuberculosis Infection Among Cancer Patients
Primary Objective:
- To evaluate the performance of the new T-SPOT.TB test and the conventional TST for screening of Latent Tuberculosis infections in patients with cancer and those undergoing Hematopoietic Stem Cell Transplant.
Secondary Objectives:
- To examine the factors associated with positive response to T-SPOT.TB and the TST (tuberculin skin test) in patients with anergy.
- To determine the impact of immunosuppressive and antineoplastic therapy on the screening performance of T-SPOT.TB and the TST in cancer patients.
Read the detailed description
TB AND TB TESTS:
Patients with cancer are considered "immunocompromised." This means that, because of the cancer and the cancer treatment, the immune system does not function normally, which decreases its ability to fight off infection and disease. This immunocompromised condition places these patients (who probably had been in contact with the TB bacteria, resulting in latent, or inactive, TB) at risk for active TB. Latent TB does not cause symptoms or signs of active TB infection. It is very important to identify patients who are at risk for developing active TB, so that they can receive timely treatment for TB.
The Tuberculin skin test (TST) is currently used to detect latent TB. The TST is considered to have low detection sensitivity, which means that it may not always detect latent TB, which may then turn into an active TB infection.
The T-SPOT.TB is a new test that researchers want to study to see whether it may be more effective and accurate than the TST at identifying patients at risk for developing active TB.
STUDY PARTICIPATION:
If you agree to take part in this study, you will have the following tests done and steps taken.
- You will have extra blood (about 1 to 2 teaspoons) drawn. It will be done at the same time as your routine clinic visit to M. D. Anderson or as a regular blood draw if you are already admitted in the hospital. This blood will be used to perform the T-SPOT. TB test.
If you have had a TST (or tuberculin skin test) performed at M. D. Anderson in the past 45 days, it may probably not be necessary to repeat the TST. However, the research staff will decide if you need to have a new TST.
You may have the TST performed before or after your blood is drawn. In any case, you will rest for 10 minutes after the blood draw.
- You will receive a fluid called tuberculin in order to have the TST performed. Tuberculin will be injected just beneath the surface of the skin on your forearm. You should then see a very small raised area of skin where the injection was given. This reaction will wear off in a few days.
- After 2-3 days (48-72 hours later), you will return to M. D. Anderson (if you are not in the hospital), and a health care professional will look at and measure any swelling or redness at the site of TST. The doctor will then learn if your TST result is positive or negative. If your TST is positive the study doctor will discuss it with , your primary doctor for further evaluation and treatment.
Although you will be informed about the TST result, you will not be informed about the T-SPOT. TB test result because the T-SPOT. TB test is just used for investigational purposes in this study and will not be used for diagnostic purposes. The study doctor will use the results of the T-SPOT. TB test to make research comparisons with the TST test results.
LENGTH OF STUDY:
Your participation will be over in this study once both TB tests have been performed and the TST has been checked by a health care professional.
This is an investigational study. The TST is FDA approved and commercially available. The T-SPOT.TB test is not FDA approved or commercially available. It is authorized for use in research only. Up to 200 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Advanced Cancer
- Being tested
- T-SPOT TB test
- Keywords
- Advanced Cancer, Solid Tumors, Latent Mycobacterium Tuberculosis, Tuberculin Skin Test, Tuberculosis, T-SPOT TB test, TB
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-SPOT TB testOther
Extra blood draw, followed by ten minutes rest and the injection of Tuberculin subcutaneously on forearm.
| Study group | Role | What they receive |
|---|---|---|
| Latent Tuberculosis Infection | Patients with cancer at risk for developing active tuberculosis (TB). Receives: Other: T-SPOT TB test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Positive Results of T-SPOT.TB (%)
Number participants with postitive T-SPOT.TB test results compared to total positive results, derived from Center for Disease Control (CDC) Criteria used for LTBI positive skin test (i.e. a tuberculin skin test (TST) with 5 mm or more of induration). For those individuals with >5 mm induration on TST, chest radiograph performed. Fisher's exact test used to assess the association between categorical variables and the testing results of T-SPOT.TB or TST.
Measured: Study period 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2007 (estimated)
- Study startJun 2007
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amar Safdar, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507754
- Sponsor's protocol ID
- 2006-1095
- Status last verified
- Sep 2011
- First submitted
- 25 Jul 2007
- Last updated
- 26 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Latent Mycobacterium Tuberculosis Infection Among Cancer Patients
- ClinicalTrials.gov ID
- NCT00507754
- Acronym / sponsor ID
- 2006-1095
- Conditions
- Advanced Cancer
- Keywords
- Advanced Cancer, Solid Tumors, Latent Mycobacterium Tuberculosis, Tuberculin Skin Test, Tuberculosis, T-SPOT TB test, TB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 27 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
- To evaluate the performance of the new T-SPOT.TB test and the conventional TST for screening of Latent Tuberculosis infections in patients with cancer and those undergoing Hematopoietic Stem Cell Transplant.
Secondary Objectives:
- To examine the factors associated with positive response to T-SPOT.TB and the TST (tuberculin skin test) in patients with anergy.
- To determine the impact of immunosuppressive and antineoplastic therapy on the screening performance of T-SPOT.TB and the TST in cancer patients.
Detailed description
TB AND TB TESTS:
Patients with cancer are considered "immunocompromised." This means that, because of the cancer and the cancer treatment, the immune system does not function normally, which decreases its ability to fight off infection and disease. This immunocompromised condition places these patients (who probably had been in contact with the TB bacteria, resulting in latent, or inactive, TB) at risk for active TB. Latent TB does not cause symptoms or signs of active TB infection. It is very important to identify patients who are at risk for developing active TB, so that they can receive timely treatment for TB.
The Tuberculin skin test (TST) is currently used to detect latent TB. The TST is considered to have low detection sensitivity, which means that it may not always detect latent TB, which may then turn into an active TB infection.
The T-SPOT.TB is a new test that researchers want to study to see whether it may be more effective and accurate than the TST at identifying patients at risk for developing active TB.
STUDY PARTICIPATION:
If you agree to take part in this study, you will have the following tests done and steps taken.
- You will have extra blood (about 1 to 2 teaspoons) drawn. It will be done at the same time as your routine clinic visit to M. D. Anderson or as a regular blood draw if you are already admitted in the hospital. This blood will be used to perform the T-SPOT. TB test.
If you have had a TST (or tuberculin skin test) performed at M. D. Anderson in the past 45 days, it may probably not be necessary to repeat the TST. However, the research staff will decide if you need to have a new TST.
You may have the TST performed before or after your blood is drawn. In any case, you will rest for 10 minutes after the blood draw.
- You will receive a fluid called tuberculin in order to have the TST performed. Tuberculin will be injected just beneath the surface of the skin on your forearm. You should then see a very small raised area of skin where the injection was given. This reaction will wear off in a few days.
- After 2-3 days (48-72 hours later), you will return to M. D. Anderson (if you are not in the hospital), and a health care professional will look at and measure any swelling or redness at the site of TST. The doctor will then learn if your TST result is positive or negative. If your TST is positive the study doctor will discuss it with , your primary doctor for further evaluation and treatment.
Although you will be informed about the TST result, you will not be informed about the T-SPOT. TB test result because the T-SPOT. TB test is just used for investigational purposes in this study and will not be used for diagnostic purposes. The study doctor will use the results of the T-SPOT. TB test to make research comparisons with the TST test results.
LENGTH OF STUDY:
Your participation will be over in this study once both TB tests have been performed and the TST has been checked by a health care professional.
This is an investigational study. The TST is FDA approved and commercially available. The T-SPOT.TB test is not FDA approved or commercially available. It is authorized for use in research only. Up to 200 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Latent Tuberculosis Infection | – | Other: T-SPOT TB testPatients with cancer at risk for developing active tuberculosis (TB). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study participants with cancer at risk for developing active tuberculosis (TB).
Key inclusion criteria (3 listed)
- Males and females.
- Patients who are receiving chemotherapy for hematologic malignancy and solid-organ cancer.
- Patients with a Hematopoietic stem cell transplantation (HSCT) history will be included after >1 year of transplantation.
Key exclusion criteria (5 listed)
- Refusal of consent
- Individuals who, on the advice of the Primary or enrolling physician, may otherwise be at increased risk of an adverse reaction to venipuncture or tuberculin skin test administration.
- Lymphocytopenia (< 300 cells/microliter)
- Patients with known HIV infection.
- Patients with known active tuberculosis will not be included in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-SPOT TB testExtra blood draw, followed by ten minutes rest and the injection of Tuberculin subcutaneously on forearm. | Other | Latent Tuberculosis Infection |
Primary outcome
Rate of Positive Results of T-SPOT.TB (%)
Time frame: Study period 2 Years
Number participants with postitive T-SPOT.TB test results compared to total positive results, derived from Center for Disease Control (CDC) Criteria used for LTBI positive skin test (i.e. a tuberculin skin test (TST) with 5 mm or more of induration). For those individuals with >5 mm induration on TST, chest radiograph performed. Fisher's exact test used to assess the association between categorical variables and the testing results of T-SPOT.TB or TST.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2011.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amar Safdar, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Positive Results of T-SPOT.TB (%) (time frame: Study period 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2011.